Polysorb XX-5202JRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521154667), received between Jan 30, 2018 and Aug 23, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 reports).

2 other recalls cover devices cleared under the same FDA submission (K963253, K981935); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE PACKING WAS OPENED, ONLY THREE WERE FOUND INSIDE INSTEAD OF FIVE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20054849 ↗
• MalfunctionOct 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY GYNE PROCEDURE, THE NEEDLE OF THE 1ST PACKET DISENGAGED FROM THE NEEDLE SWEDGE EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8019462 ↗
• MalfunctionApr 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: THE ISSUE OCCURRED DURING LAP HYSTERECTOMY WHEREIN THE NEEDLE DETACHED. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7439905 ↗
• MalfunctionMar 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC EXCISION OF LESION OF THE UTERUS, THE NEEDLE DETACHED. THEY USED A DIFFERENT DEVICE TO COMPETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7333103 ↗
• MalfunctionMar 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, THE DEVICE NEEDLE DETACHED. THEY USED ANOTHER DEVICE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316492 ↗
• MalfunctionMar 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC EXCISION OF UTERUS LESION, THE DEVICE NEEDLE DETACHED. THEY USED ANOTHER DEVICE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316296 ↗
• MalfunctionMar 1, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE EASILY CAME OFF THE THREAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7305817 ↗
• MalfunctionFeb 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, THE DEVICE NEEDLE EASILY CAME OFF THE THREAD. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PROBLEM ON THE PATIENT STATUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7304362 ↗
• MalfunctionFeb 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING THE PATIENT, THE DEVICE NEEDLE DETACHED. ANOTHER PRODUCT WAS USED TO RE SOLVED THE ISSUE AND COMPLETE THE CASE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7297593 ↗
• MalfunctionFeb 13, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE DEVICE NEEDLE DETACHED EASILY AND FELL INTO THE CAVITY. THE NEEDLE WAS SOON RETRIEVED. THEY THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7268235 ↗
• MalfunctionFeb 9, 2018Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, THE ISSUE OCCURRED DURING A LAP MYOMECTOMY WHEREIN THE NEEDLE EASILY CAME OFF. THE PACKAGE STATED -- D-TACH. IT WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260154 ↗
• MalfunctionFeb 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: THE ISSUE OCCURRED DURING LAP MYOMECTOMY. A SUTURE WAS USED WHEREIN ITS NEEDLE WAS EASILY DETACHED. REPLACED BY A NEW DEVICE TO COMPLETE THE PROCEDURE. THE SURGERY WAS EXTENDED BY MORE THAN 30 MINUTES. NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7252649 ↗
• MalfunctionFeb 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: THE ISSUE OCCURRED DURING A PROCEDURE. WHEN THE DEVICE WAS BROUGHT INTO A TROCAR, THE NEEDLE EASILY DETACHED. NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7251156 ↗
• MalfunctionFeb 7, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HYSTERECTOMY, THE DEVICE NEEDLE CAME OFF THE THREAD. OTHER PACKETS WERE CHECKED AND THE NEEDLE CAME OFF EASILY. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THERE WAS A BLEEDING OCCURRED AS A RESULT OF THE ISSUE, BUT THERE IS NO PATIENT HARM REPORTED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7247830 ↗
• MalfunctionFeb 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ABDOMINAL HYSTERECTOMY, SURGEON FELT THAT THE NEEDLE WAS EASY TO DETACH FROM SUTURE. SALES REP CHECKED THE OTHER SUTURE REMAINING IN THE BOX AND CONFIRMED THAT THE PACKAGE INDICATING "D-TACH". THE PROCEDURE WAS COMPLETED WITHOUT ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7238975 ↗
• MalfunctionJan 31, 2018Break; Detachment of Device or Device Component; Device Packaging Compromised; Break; Detachment of Device or Device Component; Device Packaging Compromised

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NURSE CONFIRMED THAT THE NEEDLE DETACHED FROM THE SUTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7232360 ↗
• MalfunctionJan 31, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, THE PRODUCT WAS DETACHED WHILE IN USE. ITS PACKET WAS INDICATING "D-TACH". THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THE PATIENT HAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7231731 ↗
• MalfunctionJan 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TOTAL ABDOMINAL HYSTERECTOMY, NEEDLE EASILY DETACHED FROM SUTURE. AFTER THE OPERATION, SURGEON OPENED ANOTHER PACKET FROM THE SAME BOX AND PULLED NEEDLE, IT EASILY DETACHED AS WELL. THERE WAS NO REPORTED PATIENT STATUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7228929 ↗
• MalfunctionJan 30, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE NEEDLE HAD DETACHED FROM THE SUTURE. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THE NEEDLE WAS FOUND INSIDE THE TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7228890 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253, K981935. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2018 · Jun 15, 2018 · Terminated
  Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI